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Safety and efficacy of topiramate in neonates with hypoxic ischemic encephalopathy treated with hypothermia (NeoNATI)

DOI: 10.1186/1471-2431-12-144

Keywords: Neonatal hypoxic-ischemic encephalopathy, Therapeutic hypothermia, Topiramate

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Term newborns (gestational age ≥ 36 weeks and birth weight ≥ 1800 g) with precocious metabolic, clinical and electroencephalographic (EEG) signs of hypoxic-ischemic encephalopathy will be randomized, according to their EEG pattern, to receive topiramate added to standard treatment with moderate hypothermia or standard treatment alone. Topiramate will be administered at 10 mg/kg once a day for the first 3 days of life. Topiramate concentrations will be measured on serial dried blood spots. 64 participants will be recruited in the study. To evaluate the safety of topiramate administration, cardiac and respiratory parameters will be continuously monitored. Blood samplings will be performed to check renal, liver and metabolic balance. To evaluate the efficacy of topiramate, the neurologic outcome of enrolled newborns will be evaluated by serial neurologic and neuroradiologic examinations. Visual function will be evaluated by means of behavioural standardized tests.This pilot study will explore the possible therapeutic role of topiramate in combination with moderate hypothermia. Any favourable results of this research might open new perspectives about the reduction of cerebral damage in asphyxiated newborns.Current Controlled Trials ISRCTN62175998; Identifier NCT01241019; EudraCT Number 2010-018627-25In countries with a high level of perinatal care, the incidence of asphyxia responsible for moderate or severe encephalopathy is 2–3 per 1000 term infants [1,2]. The ensuing encephalopathy may present with need for resuscitation at birth, neurological depression, seizures or electroencephalographic (EEG) abnormalities. Hypoxic ischemic encephalopathy (HIE) is still the leading cause of perinatal mortality and severe neurological impairment. Mortality rate is 10% for moderate and 60% for severe HIE. About 30% of survivors with moderate and 100% with severe HIE exhibit permanent neurological disability [3,4].Encephalopathy results from the combination of red


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